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Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Digital Health Legal, in “FDA Approves First Drug with Digital Ingestion Tracking System.”

Following is an excerpt (see below to download the full version in PDF format):

The drug, the result of a joint venture between Otsuka Pharmaceutical, Inc., and Proteus Digital Health, utilizes a sensor to detect whether the patient has ingested the medication and relays information - such as the time the pill was taken - to a patch worn on the patient’s ribcage, which is then transferred to a mobile app on the patient’s smartphone. Caregivers and physicians can, with the patient’s consent, access such information through an online portal. …

The FDA has approved the product for treating ‘schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults,’ but notes that the prescribing information for the drug states that it is not for tracking drug ingestion in ‘real-time’ or during emergencies. Further, it notes that the product’s ability to improve the compliance of patients with their treatment regimen has not been shown. “Obviously the sensor’s manufacturer has big plans to work with other pharmaceutical companies. It is targeting a wide variety of chronic conditions,” notes Bradley Merrill Thompson, Member at Epstein Becker & Green, P.C. “But the FDA action stopped short of saying that the product has been shown to improve patient compliance with their treatment regimen. And that’s where companies such as these will need to go in order to get payers excited. Collecting data for the sake of data is not a long run strategy. They will have to demonstrate improved outcomes. So I would say that the [FDA] decision in November was an incremental step. The device had already been approved, so this is simply the approval of the drug with the device, but without the claim of improving patient compliance there is still much work to be done.”